Responsible for the coordinating, implementing, and evaluating of clinical research trials. This includes all phases of research: Study Initiation, Execution, Completion, and Administration. Maintains appropriate and accurate documentation of patient/study participant evaluation data. Coordinates strategies for recruitment of study participants, enrolls participants, and manages data collection and reporting for institutionally approved research studies. Ensures the requirements are met for subject enrollment and compliance from entry through follow up, investigator participation, data report submission and audits.
Recruits and screens potential study participants.
Develops and conducts patient and family education regarding research participation as it relates to diagnosis, treatments, and protocol specifications.
Performs subject evaluations, administers investigational product, and provides nursing support.
Collects study data, assists in developing data collection tools, study materials, communication and performs departmental in-services.
Performs related responsibilities as required.
Consults with the Research Manager regarding the study implementation process.
Study Initiation: Plan, organize, implement clinical trials/research studies to effectively meet goals and ensure timely completion of the study. Manage and communicate effectively with Research Manager regarding proposed projects for feasibility, including, analyzing scope of work, cost and responding to inquiries and/or complaints. Review protocol for potential operational issues and make recommendations, as needed. Create informed consents. Submit protocol, informed consents and necessary documents to Institutional Review Board (IRB) for approvals; communicate with IRB on a regular schedule if applicable. Attend IRB meetings for protocol review, as needed. Confirm that all regulatory documents are submitted to sponsor in a timely manner, e.g., 1572, Confidentiality Agreement, clinical trial agreements, IRB approval letter, Financial Disclosures, etc., as needed.
Ensure staff resumes and licenses are current. Communicate with Research Manager regarding study initiation needs. Identify needed storage space for study product. Develop study specific materials, e.g., tracking logs, templates, monitoring tools, source documents, study binders, process manuals.
Study Execution: Screen potential subjects for enrollment. Explain protocol and informed consents to subject and obtain informed consents for subject participation. Oversee patient enrollment and follow-up.
Be available for study "call" if needed. Maintain strong working knowledge of Standard Operating Procedures (SOPs), FDA regulations, and International Conference on Harmonization/Good Clinical Practice (ICH/GCP) guidelines. Complete Case Report Forms (CRFs) and study related documents, submit documents to sponsor and/or IRB, if applicable. Ensure sponsor required documents are completed, e.g., screening logs, Adverse event (A/E) forms, memo to file, etc. Plan, organize, and participate in site initiation visits and continued monitoring visits. Review the monitoring reports with the Research Manager. Ensure studies are completed on time and within budget. Communicate with outside vendors such as central laboratories, central IRBs, etc. Provide guidance and troubleshoot issues. Proactively address study concerns and develop timely resolutions. Analyze and/or report safety issues, patients care issues, and study design and/or study conduct issues. Ensure that Adverse Events (AE) and Serious Adverse Events (SAE) procedures are followed accurately and within federal regulations and sponsor guidelines. Prepare study reports, e.g., modification, amendments, Investigational New Drug (IND) reports, etc. Perform yearly review of studies, completing yearly documents required by sponsor, IRB and FDA. Review case report forms. Audit regulatory binders. Ensure timely and accurate communication with the sponsor, among research staff, and with the multiple functional areas with Institution, e.g., via regularly scheduled calls, team meetings, etc. Complete status reports and communicate with the sponsor, research staff, Research Manager and Investigator(s). Work with the key functional departments to coordinate the project-related activities to meet project goals and milestones, based on the study design. Ensure study data is submitted on-time to data management for analyses. Ensure the statistical analysis plan is complete, if applicable. Ensure information is available for final study report completion.
Communicate with Research Manager regarding resource needs and issues, e.g., supplies, equipment, etc.
Study Completion. Complete study close out procedures. Submit closeout documents to sponsor and IRB. Compose year end status report for Research Manager and research staff. Return study product, if applicable. Submit yearly post study documents, as required. Ensure study material are stored and maintained for appropriate time line.
Administration. Strong knowledge of MS Word, Excel, PowerPoint and Outlook. Demonstrate ability to prioritize multiple projects. Proven ability to independently resolve problems. Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines. Work in a fast paced environment with demonstrated ability to perform multiple competing tasks and demands. Work independently, take initiative and complete tasks to deadlines.
Assist with maintaining an updated training manual for research.
Participate in the training of other research staff as assigned.
Track project milestones and report progress and issues to Research Manager.
Create and promote positive team morale.
Discuss role responsibilities, define performance expectations, provide ongoing feedback and conduct regular performance review (verbal and written) as indicated by company policy with research staff members.
Identify skill deficiencies, and appropriate training work experience to eliminate a skill gap.
Attend SOP, IRB, GCP, ICH, and FDA training sessions.
Attend related courses, seminars, and meetings.
Ensure that skills are continually sharpened and that learning and competency building are focused on routinely.
Read professional journals and publications to stay abreast of regulations and study management and to learn scientific area.
Obtain information from the field on relevant new scientific developments that identifies needs for staff training, if applicable.
Serve as a department resource for general study related issues.
Create and/or deliver project specific training to ensure adequate training specific to project requirement, e.g., project overview, study protocol information.
Assist in providing/obtaining training that is role specific, e.g., monitoring GCP, ICH, SOPs and FDA.
Provide needed assistance as requested to effectively manage projects, schedules and deadlines, vacation schedules, sick-leave, etc.
Participate in company-required training programs.
Maintain time and attendance records as directed by Research Manager.
Follows procedure should a protocol require medications prescriptions (i.e. written or phone-in) in that all requests will be given to the Research Manager for execution of such prescription. Research RN will not phone in prescriptions for subjects.
Performs other related job duties or functions as requested or assigned.